Concentrated Exposure and Response Prevention for Children With Obsessive-compulsive Disorder

NCT06621381 | Recruiting

• 1 other identifier: 2023-07331-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the preliminary outcomes of concentrated exposure and response prevention for children with obsessive-compulsive disorder (OCD) in regular clinical practice. It is a non-randomised open label evaluation where children 6-12 years with OCD who are patients at the Child and Adolescent Psychiatry (CAP) at Uppsala University Hospital will be rectruited together with their legal guardians. The treatment will be delivered by trained therapists in regular outpatient care. The main question the study aims to answer is: What are the preliminary treatment effects of concentrated exposure and response prevention with regards to OCD-symptoms, functional impact, family accomodation and clinician ratings of severity and improvement? Participants will receive psychoeducation (in group format) and exposure and response prevention (9-12h concentrated to one week, individual format). Outcomes will be measured on structured interviews, clinician ratings, and validated questionnaires pre-treatment, post-treatment and at a six month follow-up.

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-compulsive disorder; Exposure; Response prevention; Pediatric; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• Childrens Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)

  The Childrens Yale-Brown Obsessive-Compulsive Scale is a semi-structured interview made up of 10 items rated on a 5-point Likert scale evaluating the severity of Obsessions and Compulsions across five dimensions; Frequency, Interference, Distress, Resistance, and Control, during the previous week and up to the time of interview. The total score varies between 0 and 40. Higher scores indicate higher severity of Obsessions and Compulsions.

  pre-intervention; one week after the intervention; six months after the intervention

Secondary Outcomes (5)

• Clinical Global Impression (CGI)

  pre-intervention; one week after the intervention; six months after the intervention

• Dimensional Obsessive-Compulsive Scale - Child Version (DOCS-CV)

  pre-intervention; one week after the intervention; six months after the intervention

• The Obsessive Compulsive Inventory-Child Version (OCI-CV)

  pre-intervention; one week after the intervention; six months after the intervention

• Dimensional Obsessive-Compulsive Scale - Parent Version (DOCS-PV)

  pre-intervention; one week after the intervention; six months after the intervention

• The Family Accommodation Scale for Obsessive Compulsive Disorder - Self-Rated Version (FAS-SR)

  pre-intervention; one week after the intervention; six months after the intervention

Study Arms (1)

Concentrated exposure and response prevention

EXPERIMENTAL

The intervention consists of: Psychoducation for the patients (1 session, 2-3h in group format), psychoeducation for the legal guardians (1 session, 3h in group format), exposure and response prevention (3-4 sessions, 9-12h over the course of one week, individual format), group reunions for sharing experiences, motivational work and relapse prevention ( 2 sessions, 3h)

Behavioral: Concentrated exposure and response prevention

Interventions

Concentrated exposure and response prevention BEHAVIORAL

The intervention consists of: Psychoducation for the patients (1 session, 2-3h in group format), psychoeducation for the legal guardians (1 session, 3h in group format), exposure and response prevention (3-4 sessions, 9-12h over the course of one week, individual format), group reunions for sharing experiences, motivational work and relapse prevention ( 2 sessions, 3h)

Also known as: cognitive behavioral therapy

Concentrated exposure and response prevention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The patient fulfills the diagnostic criteria of obsessive-compulsive disorder
• The patient and the legal guardians have said yes to receiving the concentrated exposure with response prevention - treatment

You may not qualify if:

• The patient/legal guardians are unable to communicate in Swedish

Sponsors & Collaborators

• Uppsala University Hospital: lead
• Uppsala University: collaborator

Study Sites (1)

Uppsala University Hospital

Uppsala, Region Uppsala, 751 85, Sweden

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Vendela Zetterqvist, Ph D, Associate Professor

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vendela Zetterqvist, Ph D, Associate professor

CONTACT

+46 (0)768107060; vendela.zetterqvist@uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: October 1, 2024
• Study Start: September 11, 2024
• Primary Completion (Estimated): December 14, 2029
• Study Completion (Estimated): December 14, 2029
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)